ISO 13485:2016
Quality Management System for Medical Devices
Quality under regulatory pressure.
Current edition: ISO 13485:2016.
What it is
What the standard covers
ISO 13485 defines quality management system requirements for organisations involved in the medical device life cycle: design, production, storage, distribution, installation and servicing. Unlike ISO 9001, its orientation is regulatory compliance and product safety, with strict requirements for traceability, change control and post-market surveillance.
Who it is for
- Medical device manufacturers
- Importers and distributors
- Laboratories and diagnostic centres
- Critical suppliers to the medical sector
Problems it helps manage
- Incomplete batch traceability
- Change control and validation without evidence
- Regulatory requirements across markets not consolidated
- Difficulty registering product with health authorities
Business benefits
- Full product traceability
- Documented control of design, changes and validation
- A solid base for product registration and regulated markets
- Lower risk of recalls and regulatory non-conformities
Sectors
Where it applies
Support
What the engagement includes
- Documented initial gap analysis
- Management system design
- Complete, tailored documentation
- Implementation support, on site or remote
- Training for the key team
- Internal audit and closure of findings
- Readiness and support through the certification audit
Integration with other standards
This standard commonly integrates with: ISO 9001, ISO/IEC 27001, ISO 14971 (risk management). An integrated system reduces duplicated documentation and audit time.
Stages
How the project runs
Gap analysis and planning
We review the real operation, not a questionnaire. We identify gaps against the standard, critical processes, existing evidence and regulatory risk.
Selecting the standard or combination
We define which standard answers the organisation's risk and objective. The choice is technical, not a matter of popularity.
Management system design
We structure processes, responsibilities, indicators and controls according to size, sector and applicable regulation.
Documentation development
We write policy, procedures, records and matrices tailored to the operation. No generic templates.
Guided implementation
We work with each process owner until the system is used day to day, not only stored in a folder.
Team training
We train the key team on the standard, on the system and on their role during the audit.
FAQ
Frequently asked questions — ISO 13485
Can we hold ISO 9001 and ISO 13485 together?
Does it apply to distributors that do not manufacture?
Does it replace product registration?
Next step
Every organisation is different. The right system starts with a gap analysis.
Write to us and we will arrange a strategy meeting: we review your current situation, define the right system, set scope and timelines and resolve technical and regulatory questions.
A certification done properly is not chased. It is built.